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ICH elemental impurities guideline sets a global policy for limiting metal impurities in drug products and ingredients.
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Steering Committee has moved Q3D Guideline on Elemental Impurities to Step 4 of the ICH process, recommending it for adoption by regulatory agencies. The guideline now enters the implementation period (Step 5), which is carried out according to national or regional procedures that apply to other regional regulatory guidelines and requirements in the European Union, Japan, United States, Canada, Switzerland, and other areas.
Q3D, which is available for download on the ICH website, applies to new finished drug products (as defined in ICH Q6A and Q6B) and new drug products containing existing drug substances, provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients. According to the Q3D document, it “presents a process to assess and control elemental impurities in the drug product using the principles of risk management as described in ICH Q9. This process provides a platform for developing a risk-based control strategy to limit elemental impurities in the drug product.”
Impurities are classified in an existing ICH Q3A guideline as “organic, inorganic, and residual solvents,” and Q3A and Q3B discuss requirements for organic impurities. ICH Q3C provides clarification of the requirements for residual solvents. The new Q3D guideline would provide similar clarification of the requirements for metals, which are included in the ICH inorganic impurities classification.